Age
Item
1. age ≥18 years old.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
2. female.
boolean
C0079399 (UMLS CUI [1])
Triple-Negative Breast Cancer | Breast adenocarcinoma | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | Immunohistochemistry | erbB-2 Receptor | Fluorescent in Situ Hybridization Negative | Chromogenic in situ Hybridization Negative | ASCO Guidelines
Item
3. histological diagnosis of triple-negative breast cancer (tnbc) breast adenocarcinoma (er<1%, pr<1% by (ihc) and her-2 0-1+ by ihc or ihc 2+ and fish or cish negative per updated asco guidelines).
boolean
C2348819 (UMLS CUI [1])
C0858252 (UMLS CUI [2])
C2919271 (UMLS CUI [3])
C2919590 (UMLS CUI [4])
C0021044 (UMLS CUI [5])
C0069515 (UMLS CUI [6])
C0162789 (UMLS CUI [7,1])
C0205160 (UMLS CUI [7,2])
C1516514 (UMLS CUI [8,1])
C0205160 (UMLS CUI [8,2])
C1515948 (UMLS CUI [9,1])
C0162791 (UMLS CUI [9,2])
Distant Metastasis
Item
4. no clinical or radiologic evidence of distant metastasis.
boolean
C1269798 (UMLS CUI [1])
Primary disorders Residual | Ultrasonics (sound) | Magnetic Resonance Imaging | Anthracyclines Taxanes, antineoplastic Neoadjuvant Therapy Chemotherapy
Item
5. presence of residual primary disease of at least 1.5 cm by u/s or mri within 14 days preceding the last cycle of standard anthracycline and taxane-based neoadjuvant chemotherapy.
boolean
C0277554 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C1456803 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0282564 (UMLS CUI [4,1])
C3541958 (UMLS CUI [4,2])
C0600558 (UMLS CUI [4,3])
C3665472 (UMLS CUI [4,4])
bilateral breast cancer | Unilateral Breast Carcinoma Multifocal | Multicentric Breast Carcinoma | Triple-Negative Breast Cancer Finding | Biopsy
Item
patients with synchronous synchronous bilateral cancer and unilateral multifocal or multicentric or bilateral disease breast cancer will be allowed provided histologic diagnosis of tnbc is found on all performed biopsies.
boolean
C0281267 (UMLS CUI [1])
C1710547 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
C2986664 (UMLS CUI [3])
C2348819 (UMLS CUI [4])
C0005558 (UMLS CUI [5])
Anthracyclines Taxanes, antineoplastic Neoadjuvant Therapy Chemotherapy Complete | Platinum-based Drug
Item
6. completion of standard anthracycline and taxane-based neoadjuvant chemotherapy. the use of platinum agents in combination with standard neoadjuvant chemotherapy is allowed.
boolean
C0282564 (UMLS CUI [1,1])
C3541958 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C3665472 (UMLS CUI [1,4])
C0205197 (UMLS CUI [1,5])
C2266918 (UMLS CUI [2])
ECOG performance status
Item
7. ecog performance status (ps) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Function | Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
8. adequate bone marrow function: absolute neutrophil count (anc) ≥ 1500/μl or ≥1.5 x 109/l; platelets ≥100000/μl or ≥100 x 109/l; hemoglobin ≥ 9 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Upper Limit of Normal | Creatinine clearance measurement
Item
9. adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal (uln) or estimated creatinine clearance ≥ 60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1519815 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Upper Limit of Normal | Gilbert Disease | Aspartate Transaminase | Alanine Transaminase | Alkaline Phosphatase
Item
10. adequate liver function:total serum bilirubin ≤ 1.0 x uln or ≤ 2 x uln in cases of known gilberts syndrome; aspartate and alanine aminotransferase (ast and alt) ≤ 1.5 x uln; alkaline phosphatase ≤ 2.5 x uln.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1519815 (UMLS CUI [3])
C0017551 (UMLS CUI [4])
C0004002 (UMLS CUI [5])
C0001899 (UMLS CUI [6])
C0002059 (UMLS CUI [7])
Childbearing Potential Serum pregnancy test negative Urine pregnancy test negative Hormonal contraception
Item
11. for patients of childbearing potential: negative serum/urine pregnancy test and use accepted forms of non-hormonal contraception during the study period and up to 6 months after treatment completion.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0430057 (UMLS CUI [1,3])
C2985296 (UMLS CUI [1,4])
cancer treatment Breast Carcinoma | Hormone Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Immunotherapy | Study Subject Participation Status Investigational New Drugs
Item
1. concurrent anti-cancer therapy for current breast cancer (hormone therapy, chemotherapy, radiotherapy, immunotherapy). patients already included in another therapeutic trial involving an experimental drug.
boolean
C0920425 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C2348568 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
History of invasive malignant neoplasm of breast
Item
3. any prior history of invasive breast cancer.
boolean
C4040792 (UMLS CUI [1])
H/O: malignant neoplasm | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
4. any previous history of non-breast malignancies (excepted basal cell carcinoma or squamous cell carcinoma of the skin) in the preceding 5 years.
boolean
C0455471 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
5. known hypersensitivity to the study drug or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Comorbidity Study Subject Participation Status Limited
Item
6. patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Unable to swallow oral medication
Item
7. subjects unable to swallow oral medications.
boolean
C0221470 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])